12 results
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18ms
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Sources: EU EUDAMED, US FDA
PET-SCOPE II MODEL DIS-1611
FDA 510(k)
FDA Class 2
·Radiology
CODMAN MALIS
FDA UDI
Cerenovus, Inc.·10886704035862·CODMAN MALIS Interconnecting Footpedal Cable
ACUMED
FDA UDI
Acumed LLC·10806378047183·25mm SLIC Screw® Easyout
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209119141·KIT, DOOR PANEL - BASIC - BLK
LIGHTSTREAM LOW LEVEL LASER
FDA 510(k)
FDA Class 2
·Physical Medicine
ULTRA V THERAPEUTIC ULTRASOUND
FDA 510(k)
FDA Class 2
·Physical Medicine
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·May 8, 2014
LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·October 23, 2012
SYNCHROMED
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·August 11, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012